Moderate Republican Tennessee Sen. Lamar Alexander and liberal Democratic lawmakers Tom Harkin and Rosa DeLauro are among those pushing for legislation that would expand the size and regulatory scope of the Food and Drug Administration (FDA), raising concern from experts who fear that the legislation would have adverse consequences for the pharmaceutical industry.
Connecticut Rep. Rosa DeLauro and New York Rep. Nita Lowey, both Democrats, introduced a bill in the House on Dec. 5 called the “Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act.”
DeLauro said the bill was a response to a fungal meningitis outbreak this fall caused by contaminated steroid injections produced at the now-defunct New England Compounding Center in Framingham, Mass. The outbreak reportedly resulted in more than 500 illnesses and 36 deaths.
A compounding pharmacy combines different ingredients to create new drug treatments for specific patients, based on specific prescriptions from doctors. The majority of all U.S. pharmacies provide compounding services, and 7,500 pharmacies specialize in compounding.
The New England Journal of Medicine pointed out that the New England Compounding Center was in clear violation of existing FDA policy on at least three major counts. The center essentially ignored the patient-by-patient nature of traditional compounding and acted instead as a drug manufacturer.
“It’s important to recognize that compounding pharmacies are already regulated fairly strictly. This is not a problem that arose from a lack of regulation. It arose from a willful effort to evade the regulations that already exist,” Gregory Conko, senior fellow at the Competitive Enterprise Institute, told The Daily Caller. “The New England Compounding Center has a history of evading those regulations.”
Nevertheless, the SAFE Compounded Drugs Act would give the FDA broad new regulatory powers over the entire compounding industry, including the thousands of pharmacies currently operating within the rules.
DeLauro and Lowey’s bill “would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders.”
It also “would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators.”
“There is really a regulatory morass out there with outrageous gaps in the system and the SAFE Compounding Drugs Act seeks to close those gaps, taking common-sense steps like improving standards and enhancing communication,” DeLauro told TheDC in a statement.
“The language of the bill is fairly rudimentary, but it doesn’t give any direction to the FDA,” Conko said. “It essentially writes a blank check for a regulatory authority that we know has a history of wanting to shut down pharmacies. It could result in rule-making that could destroy the industry.”
“We are reviewing the proposed legislation and look forward to working with Congress and other stakeholders to strengthen FDA’s authority over compounding pharmacies…we need a clear path forward that is proactive and preventive and that takes the need for compounded products and the evolution and potential risks of pharmacy compounding into consideration,” an FDA representative told TheDC in statement.
Though DeLauro only confirmed to TheDC that she worked with Lowey on the bill, insiders believe the creation of the SAFE Compounded Drugs Act actually began in the U.S. Senate, where its goals were pushed for by Lamar Alexander and DeLauro’s longtime ally and Huffington Post co-blogger, Tom Harkin.
Alexander, who is expected to become the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee in the next Congress, spoke at a HELP Committee hearing Nov. 15 called “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.”
Alexander said at the hearing that he is working with HELP Chairman Sen. Tom Harkin, a liberal Iowa Democrat, on legislation “to be introduced early in the next Congress.”
“[FDA’s] job would be more like, say, the Nuclear Regulatory Commission,” Alexander said.
FDA could “certify a state agency as adequate to [regulate] sterile compounding or inadequate to do it,” according to Alexander.
“The FDA could set standards and certify the state to handle that narrow area of compounding — and be able to take it away … if FDA had the authority, it should jerk the ability of Massachusetts to deal with these sorts of entities at least until Massachusetts cleaned up its act,” Alexander said.
FDA Commissioner Margaret Hamburg said, in regard to Alexander’s plan, “that would certainly be one model that could work.”
Alexander’s close working relationship with Harkin is currently the source of speculation on Capitol Hill.
In addition to the HELP Committee, Alexander is also a top candidate to become ranking member of the Labor, Health, and Human Services Subcommittee, which Harkin chairs. That would create a “parallel leadership structure” between Alexander and Harkin across two committees.
Alexander has been planning his next power play in the Senate since stepping down as Republican conference chairman in January to focus on “creating bipartisan coalitions.”
The offices of Alexander, Harkin, and Lowey did not immediately return requests for comment.